Lucentis Side Effects and Applications
Recently, FDA has approved Genentech's Lucentis (ranibizumab
injection) for the treatment of patients with neovascular (wet)
age-related macular degeneration (AMD). Lucentis is the first
treatment which, when dosed monthly, can maintain the vision of
more than 90 percent of patients with this type of AMD. Lucentis is
a new molecular entity (NME), meaning it contains an active
substance that has never before been approved for marketing in
any form in the United States. Lucentis will be the first
FDA--approved product to provide prescription information in the
new format for prescription drug package inserts, to provide
professionals and consumers clear and concise prescription
information.

ABOUT LUCENTIS

Lucentis, a biologic product, administered by injection into the eye,
was shown to be safe and clinically effective in three multicenter,
randomized studies of patients representative of the population
usually affected with AMD. In clinical trials, nearly 95 percent of the
participants who received a monthly injection maintained their
vision at 12 months compared to approximately 60 percent of
patients who received the control treatment.
Approximately one-third of patients in these trials had improved
vision at 12 months. In a single study carried out for 24 months,
these findings have been maintained with continued monthly
dosing. The most commonly reported side effects or adverse
events included conjunctival hemorrhage, eye pain, floaters,
increased eye pressure and inflammation of the eye.  Serious side
effects were rare and often related to the injection procedure
including endophthalmitis (severe inflammation of the interior of
the eye), intraocular inflammation, retinal detachment, retinal tear,
increased eye pressure and traumatic cataract.

ABOUT AGE-RELATED MACULAR DEGENERATION

According to the FDA news release, this approval is of great
importance for the 155,000 Americans who are diagnosed each
year with AMD, a common cause of severe and irreversible vision
loss in older adults. As our population is aging rapidly, this product
preserves quality of life for those affected by this disease, helping
the seniors to regain the ability to participate in everyday activities
such as reading and driving.  AMD, a retinal disease causing severe
and irreversible vision loss, is a major cause of blindness in
individuals older than 55 years. Untreated, the majority of eyes
affected with wet AMD may become functionally impaired. Wet
AMD, which accounts for 10 percent of all AMD, is responsible for
80 percent of the associated vision loss. The vision loss in wet
AMD is caused by the growth of abnormal leaky blood vessels that
eventually damage the area of the eye responsible for central
vision. Lucentis is designed to block new blood vessel growth and
leakiness, which ultimately lead to disease progression and such
vision loss.

LUCENTIS MECHANISM

Vascular endothelial growth factor (VEGF) is believed to play an
important role in the pathogenesis of age-related macular
degeneration due to its vascular permeability-inducing and
angiogenic properties. Lucentis, a small antibody fragment,
competitively bind all VEGF isoforms, passes after intravitreal
injection all retinal layers reaching the retinal pigment
epithelium-choroid complex.

Animal studies showed Lucentis to be safe and effective.
Subsequently, Phase I/II clinical trials conducted in patients with
neovascular AMD demonstrated a good safety profile, and a
significant functional benefit. Lucentis therapy repeated every four
weeks for the treatment of neovascular AMD is currently in Phase
III clinical trials. Combination therapy trials aiming for improved
treatment durability and effectiveness are currently ongoing as well
as new treatment strategies using intermittent, optical coherence
tomography (OCT) guided therapy. Anti-VEGF therapy using
Lucentis is a promising new treatment option for neovascular AMD.
[2]

HEALTH FOOD SUPPLEMENTS AND DIET FOR AGE-RELATED
MACULAR DEGENERATION

A recent report indicates eating fish frequently may be associated
with decreased chances of developing age-related macular
degeneration. It is also believed that combined healthy diets (e.g.
non-smoking, rich in omega-3 fatty acids), health food
supplements (such as ginkgo biloba, vitamins C and E, lutein and
zeaxanthin), examinations, and proper treatments may reduce
age-related macular degeneration blindness.

ALL RIGHTS RESERVED 2006 ZHION THIS ARTICLE IS FOR YOUR REFERENCE ONLY.
YOU SHOULD CONSULT WITH YOUR DOCTOR FOR ANY QUESTIONS.

[1] FDA Approves New Biologic Treatment for Wet Age-Related Macular Degeneration
FDA Online Publication June 30, 2006. Rosenfeld PJ, et al, Tolerability and efficacy of
multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related
macular degeneration. Ophthalmology. 2006 Apr;113(4):632.e1. [2] Michels S,
Rosenfeld PJ. Treatment of neovascular age-related macular degeneration with
Ranibizumab/Lucentis Klin Monatsbl Augenheilkd. 2005 Jun;222(6):480-4.
PHARMCEUTICAL
THIS WEBSITE TALKS ABOUT THE SIDE EFFECTS AND THE POTENTIAL HEALTH BENEFITS OF HERBS, SUPPLEMENTS,